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ID

23644

Beschrijving

Responsible Party: Center for Sepsis Control and Care, Germany ClinicalTrials.gov Identifier: NCT02734550 History of Changes Other Study ID Numbers: ZKSJ0087 01EO1502 ( Other Grant/Funding Number: Federal Ministry of Education and Research of Germany ) U1111-1181-8724 ( Registry Identifier: Universal Trial Number ) DRKS00010285 ( Registry Identifier: German Clinical Trial Register ) Study First Received: April 6, 2016 Last Updated: January 27, 2017 (1,3)-β-D-glucan Based Diagnosis of Invasive Candida Infection in Sepsis (CandiSep) ODM derived from: https://clinicaltrials.gov/ct2/show/NCT02734550

Link

https://clinicaltrials.gov/ct2/show/NCT02734550

Trefwoorden

Versies (1)
  1. 10-07-17 10-07-17 -
Geüploaded op

10 juli 2017

DOI

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Creative Commons BY 4.0
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    Eligibility Sepsis NCT02734550 DRKS00010285

    Engels

    Eligibility Sepsis NCT02734550 DRKS00010285

    1 Formulieren  
    Inclusion Criteria
    Beschrijving

    Inclusion Criteria

    Alias
    UMLS CUI-1
    C1512693
    Severe sepsis or septic shock
    Beschrijving

    Severe sepsis or septic shock

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C1719672
    UMLS CUI [2]
    C0036983
    Onset of sepsis no longer than 12 hours
    Beschrijving

    Onset

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0574845
    Increased risk of invasive candida infection with at least one of the following criteria: - total parenteral nutrition ≥48 hours - abdominal surgery within the last 7 days - antimicrobial therapy for at least 48 hours within the last 7 days - Acute or chronic renal failure with renal replacement therapy
    Beschrijving

    Risk of invasive candida infection

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0035647
    UMLS CUI [1,2]
    C0006840
    Age ≥18 years
    Beschrijving

    Age

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    Informed consent of the patient or legal representative or delayed consent process is started if patient is incapable of giving informed consent and no legal representative is available.
    Beschrijving

    Informed Consent

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Exclusion Criteria
    Beschrijving

    Exclusion Criteria

    Alias
    UMLS CUI-1
    C0680251
    Pregnant or lactating women
    Beschrijving

    Gynaecological Status

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    Ongoing invasive candida infection
    Beschrijving

    Ongoing invasive candida infection

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0006840
    UMLS CUI [1,2]
    C0549178
    Systemic antifungal therapy
    Beschrijving

    Antifungal therapy

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0678026
    Liver cirrhosis Child C
    Beschrijving

    Child Pugh Score

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C4055253
    Cardiopulmonary bypass within the last 4 weeks
    Beschrijving

    Cardiopulmonary bypass

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0007202
    Treatment with immunoglobulins within the last 14 days
    Beschrijving

    Immunoglobulin Therapy

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0021022
    Immunosuppression (solid organ transplantation, AISA, leukopenia)
    Beschrijving

    Immunosuppression

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0021079
    Participation in another intervention study
    Beschrijving

    Study Participation Status

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C2348568
    No commitment to full therapy (i.e. DNR order)
    Beschrijving

    Commitment

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0870312
    Unfavourable prognosis due to secondary diseases
    Beschrijving

    Prognosis

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0033325
    Kin to or colleague of study personnel
    Beschrijving

    Relationship

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0015608
    Healthy Volunteers
    Beschrijving

    Control Group

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0009932
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    Similar models

    Eligibility Sepsis NCT02734550 DRKS00010285

    1 Formulieren
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    Inclusion Criteria
    C1512693 (UMLS CUI-1)
    Severe sepsis or septic shock
    Item
    Severe sepsis or septic shock
    boolean
    C1719672 (UMLS CUI [1])
    C0036983 (UMLS CUI [2])
    Onset
    Item
    Onset of sepsis no longer than 12 hours
    boolean
    C0574845 (UMLS CUI [1])
    Risk of invasive candida infection
    Item
    Increased risk of invasive candida infection with at least one of the following criteria: - total parenteral nutrition ≥48 hours - abdominal surgery within the last 7 days - antimicrobial therapy for at least 48 hours within the last 7 days - Acute or chronic renal failure with renal replacement therapy
    boolean
    C0035647 (UMLS CUI [1,1])
    C0006840 (UMLS CUI [1,2])
    Age
    Item
    Age ≥18 years
    boolean
    C0001779 (UMLS CUI [1])
    Informed Consent
    Item
    Informed consent of the patient or legal representative or delayed consent process is started if patient is incapable of giving informed consent and no legal representative is available.
    boolean
    C0021430 (UMLS CUI [1])
    Item Group
    Exclusion Criteria
    C0680251 (UMLS CUI-1)
    Gynaecological Status
    Item
    Pregnant or lactating women
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    Ongoing invasive candida infection
    Item
    Ongoing invasive candida infection
    boolean
    C0006840 (UMLS CUI [1,1])
    C0549178 (UMLS CUI [1,2])
    Antifungal therapy
    Item
    Systemic antifungal therapy
    boolean
    C0678026 (UMLS CUI [1])
    Child Pugh Score
    Item
    Liver cirrhosis Child C
    boolean
    C4055253 (UMLS CUI [1])
    Cardiopulmonary bypass
    Item
    Cardiopulmonary bypass within the last 4 weeks
    boolean
    C0007202 (UMLS CUI [1])
    Immunoglobulin Therapy
    Item
    Treatment with immunoglobulins within the last 14 days
    boolean
    C0021022 (UMLS CUI [1])
    Immunosuppression
    Item
    Immunosuppression (solid organ transplantation, AISA, leukopenia)
    boolean
    C0021079 (UMLS CUI [1])
    Study Participation Status
    Item
    Participation in another intervention study
    boolean
    C2348568 (UMLS CUI [1])
    Commitment
    Item
    No commitment to full therapy (i.e. DNR order)
    boolean
    C0870312 (UMLS CUI [1])
    Prognosis
    Item
    Unfavourable prognosis due to secondary diseases
    boolean
    C0033325 (UMLS CUI [1])
    Relationship
    Item
    Kin to or colleague of study personnel
    boolean
    C0015608 (UMLS CUI [1])
    Control Group
    Item
    Healthy Volunteers
    boolean
    C0009932 (UMLS CUI [1])
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